The reason for this instrument failure was reported as broken humeral component.The healthcare professional indicated that this event occurred during surgery, near the patient.No risk or adverse event was reported by the surgeon.The surgery was completed as intended, with no delay.The instrument was inspected prior to use and was deemed acceptable for use based on its appearance.The agent was present during surgery and was able to source a suitable replacement device.The devices were disposed of at hospital and not made available to djo surgical for examination.The instrument was not returned for examination and the lot number was not reported.Without the lot number, the instrument could not be linked to a specific device history record (dhr) and the actual date of manufacture cannot be determine with confidence.Complaint database review shows four prior complaints filed against the instruments' item number that reports a similar failure.Those are 4 - broke/cracked/damaged.No prior complaints report past instances of these instruments being affected by this failure.The root cause for the initial problem cannot be determined with confidence as the instrument was not returned for investigational review.It is likely attributable to damage incurred from prolonged use and through misuse or rough handling which surgical instruments are subjected to.This is not an event associated with a product failure, malfunction or issue.There are no indications that this instrument has a systemic design or material deficiency.Therefore, no containment of inventory is required.Rma examination: the reported instrument was not returned to djo therefore no further evaluation can be made for this event.This customer complaint will be closed.If the device is returned later, the complaint will be updated.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
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